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Envafolimab - Alphamab Oncology/Ascletis/3D Medicine

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Drug Profile

Envafolimab - Alphamab Oncology/Ascletis/3D Medicine

Alternative Names: ASC 22; ENWEIDA; KN-035

Latest Information Update: 08 Apr 2024

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At a glance

  • Originator Alphamab Oncology
  • Developer 3D Medicines; Alphamab Oncology; Ascletis; Chipscreen Biosciences; Jiangsu Simcere Pharmaceutical; Sun Yat-Sen University; The First Affiliated Hospital of Xiamen University; TRACON Pharmaceuticals
  • Class Antibodies; Antineoplastics; Antiretrovirals; Antivirals; Immunotherapies; Recombinant fusion proteins; Single-domain antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death-1 ligand-1 inhibitors; T lymphocyte stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Biliary cancer; Soft tissue sarcoma
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Solid tumours
  • Phase III Biliary cancer; Non-small cell lung cancer
  • Phase II Endometrial cancer; Gastrointestinal cancer; Hepatitis B; HER2 positive breast cancer; HIV infections; Liver cancer; Malignant fibrous histiocytoma; Renal cell carcinoma; Soft tissue sarcoma

Most Recent Events

  • 03 Apr 2024 Efficacy data from a phase II ENVASARC trial for Malignant fibrous histiocytoma and Soft tissue sarcoma released by TRACON Pharmaceuticals
  • 13 Mar 2024 Jiangsu Simcere Pharmaceutical terminated a phase II trial in Solid tumours (Combination therapy, Late-stage disease, Second-line therapy or greater) in China (SC), due to the sponsor's research and development strategy adjustment (NCT05148195)
  • 06 Feb 2024 CTP push: 700368762: Updated KDM, added devline as qualifier was different than previous devlines
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